1Aseptic processing and sterility assurance
Y our firm has not established adequate written Standard Operating Procedures to ensure proper maint enance of aseptic processing areas and equipment used in those areas.
Inspection Record
Specialty Compounding LLC. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Your firm has not ensured that your facility is suitably designed with respect to the flow of personnel, in-process materials and finished sterile drugs, the need for room segregation and process separation: and the impact from heating ventilation and air conditioning (HVAC), air pressurization, and unidirectional airflow, to prevent contamination and other hazards to sterile drugs .
3Aseptic processing and sterility assurance
Your firm has failed to establish and implement adequate operational procedures designed to prevent microbiological contamination of drugs purporting to be sterile.
4Aseptic processing and sterility assurance
Your firm has not established adequate written Standard Operating Procedures to ensure proper maintenance of aseptic processing areas and equipment used in those areas.
5Aseptic processing and sterility assurance
Your firm has failed to establish adequate procedures for conducting appropriate media fill simulations.
6Aseptic processing and sterility assurance
Your firm has not established adequate written S tandard Operating Procedures to ensure proper maintenance of aseptic processing areas and equipment used in those areas.
7Aseptic processing and sterility assurance
Yo ur fi rm has failed to establish and implement a dequate operational procedures designed to prevent microbiologi cal contamination of drugs purporting to be sterile.
8Aseptic processing and sterility assurance
Your firm has not ensured that your facility is suitably designed with respect to the flow of personnel, in-process materials and finished sterile drugs, the need for room segregation and process separation: and the impact from heating ventilation and air conditioning (HVAC), air...
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
